DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 20, 2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below. It is noted that Applicant’s arguments directed to the disclosure of an obturator by Dubrul are not persuasive. An obturator is simply a support device used for passing another device therethrough during a procedure. A prior art device need not explicitly be described as an obturator to fulfil such a function. If Applicant wishes to limit the scope of the claimed obturator then suitable structure should be included that cannot be taught by the prior art device of Dubrul. In addition, it appears as if Applicant has mischaracterized the disclosure of Dubrul as it is clearly set forth that the proximal end of access tube is element 72, and they are therefore attached throughout use. The rejection has been modified only to provide support for placing the flange member on the proximal end of tube 72 of Dubrul to engage with the splittable sheath 110. In addition, any structure capable of being held is considered a handle. Therefore the proximal portions of the sheath and access tube of Dubrul are considered handles as claimed and need not explicitly be disclosed as handles in order to anticipate the prior art.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 22 and 24-34 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dubrul (US 5,454,790) in view of Lee (US 5,125,904), and further in view of Dorsey (US 5,505,710).
Regarding claims 22 and 34, Dubrul discloses (Figures 15-16) a medical device for creating access into the soft tissue of the brain or spine (Col. 4, lines 59-62 disclose the use of the device for accessing a region to be treated within the body; the tissue surrounding the spine is considered “soft” and easy to access and as such the device of Dubrul would be fully capable of accessing such a region based upon the disclosure), comprising: a sheath (80) defined by an open distal end (to allow tip 102 to extend therethrough), an open proximal end (for receiving the distal end of 72), a lumen located between the open distal and proximal ends (for receiving shaft of 72); an obturator (72, 78) having a distal end portion (passing through sheath 80), a proximal end portion (78) and a body portion therebetween (comprising shaft 72; the obturator is also hollow as per claim 34 for receiving the navigation probe), the obturator insertable within the sheath to an introducing configuration (at Figure 16), whereby the distal end portion extends outside the open distal end of the sheath (the stylet extends distal end 76) and a handle portion disposed adjacent the proximal end portion (the tapered proximal end of 72 including 78 is capable of being held by a user and therefore constitutes a handle), wherein the handle portion is configured ; wherein the obturator includes a probe receptacle (inner surface of 76; see also Figures 1-3 which depict the same distal end Malecot structure as Figures 14-16) located at the distal end portion, the probe receptacle having an inner surface that tapers continuously from a first lateral size to a second lateral size (see Figures 1-3 for the Malecot structure which comprises a conical section tapering to an apex), the first lateral size being greater than the second lateral size forming an apex (see Figures 1 and 3); and a navigation (88) probe having a distal tip (94) and configured to extend into the soft tissue while within the obturator to and indicate a position of the sheath within the soft tissue in the introducing configuration (Col. 5, line 67-Col. 6, line 16), wherein the navigation probe is configured to be disposed within the sheath and is configured to be coupled to at least one of the sheath and the obturator (Figure 16, via 92), wherein a distal end of the navigation probe does not extend past the open distal end of the sheath when the navigation probe is disposed within the sheath in the introducing configuration (the introducing configuration is set forth as a relationship between the sheath and obturator; therefore, for the purposes of interpreting the navigation element position, the Examiner maintains the interpretation whereby the navigation probe may be retracted to a position proximal of the distal end of the sheath after insertion wherein the sheath will still be in the claimed position relative to the obturator; if the claim were amended to set forth that the navigation probe was configured to be coupled to at least one of the sheath and the obturator in the introducing configuration without extending beyond the distal end of the sheath, it would overcome such an interpretation), and wherein the inner surface of the obturator is configured and dimensioned to receive the distal tip of the probe to seat the navigation probe at the apex of the obturator when in the introducing configuration to align the distal tip of the probe within the same plane as the distal end portion of the outer sheath (see Figures 3 and 16 for the engagement of the distal end of the navigation probe and obturator), and a locking member (92) is directly adjacent the navigation probe (it can be seen in Figure 15 that the locking member is directly adjacent the probe body 86; the claim does not require the locking member to directly engage a surface of the navigation probe) and secures the navigation probe to the obturator by frictional engagement (it’s a latch member as per Col. 8, lines 60-64 and secures the probe to the obturator via engagement with the groove in 78). Dubrul fails to explicitly disclose wherein in the introducing configuration, a mounting flange is seated within the mounting groove.
Lee teaches (Figures 2-3) a combined medical device assembly comprising a first sheath element (splittable sheath 12) engaged with a proximal external element (16b of valve body) wherein the inner and outer elements are engaged via a mounting flange (Figure 2; it can be seen that the proximal end of splittable sheath 12 comprises an annular groove for receiving the distal end of valve portion 16b therein to secure the valve body to the sheath) and corresponding groove (Figure 2, the groove in valve portion 16b receives the flange from the splittable sheath 12).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the connection between the obturator and sheath of Dubrul to comprise the locking features of Lee to provide a means of releasably securing the obturator to the sheath before disconnecting them after placement. Lee teaches a method of connection two portions of coaxial medical devices, one of which is a splittable sheath such as that disclosed by Dubrul, for the purpose of securing them together during use.
As above, neither Dubrul nor Lee teach a handle portion as a flange member extending around an outer periphery of the obturator.
Dorsey teaches a medical device (e.g., telescoping probe base 14) comprising a handle formed as a flange (it can be seen in Figures 1-3 that the proximal portion is flanged out around the body forming an area which can be gripped by a user) extending around an outer periphery of the device.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the proximal end of the obturator of Dubrul/Lee to comprise the flanged portion of Dorsey to provide a secure means of gripping and manipulating the obturator of Dorsey/Lee during use.
Regarding claim 24, Dubrul further discloses wherein the probe retainer is operable to fix the navigational probe from movement in the lateral direction (the latch arm engages proximal end of 78 thereby restricting lateral and axial movement of the navigation probe relative to the obturator).
Regarding claim 25, Dubrul further discloses herein the probe retainer includes a fastening element that is configured to selectively connect to the navigational probe (flange portion of 92).
Regarding claim 26, Dubrul further discloses wherein the navigation probe is coaxial with the obturator, when in the introducing configuration (Figure 16).
Regarding claim 27, Dubrul further discloses wherein the inner surface is configured to position the distal tip of the navigational probe with respect to the obturator distal end portion (Figure 16).
Regarding claim 28, Dubrul further discloses wherein the probe receptacle inhibits the distal tip of the navigational probe from extending beyond a distal end of the obturator (the receiving portion of the obturator which is distal end 76 prevents the distal tip 94 of the navigation probe from passing completely through the closed end of the obturator forming the apex portion).
Regarding claim 29, Dubrul further discloses wherein the navigational probe is centered within the obturator when engaged with the probe receptacle (see e.g., Figure 3 which depicts an analogous configuration to that of Figure 16).
Regarding claim 30, Dubrul further discloses wherein the distal tip of the navigational probe is centered at the probe receptacle (see e.g., Figure 3 which depicts an analogous configuration to that of Figure 16 and shows the probe as centered with the obturator).
Regarding claim 31, Dubrul further discloses wherein at least a portion of the navigational probe receptacle has a conical shape (see Figures 1, 3, and 16 which depict the conical distal tip section of the obturator as claimed).
Regarding claim 32, Dubrul further discloses wherein the distal end portion is contoured to a narrow closed distal end tip (Figures 1, 3, and 16).
Regarding claim 33, Dubrul further discloses wherein the distal tip is blunt (Figure 15, the distal tip is rounded; Col. 8, lines 3-5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783